Systems and methods for implant delivery

ABSTRACT

Some embodiments of the present disclosure are directed generally to systems and methods for delivering an implant to a body vessel of a patient. Such disclosed implants may be a monofilament implant, and disclosed systems for implanting the implant may be automatic. Some embodiments may enable retraction of said implant back into the delivery system following partial exteriorization of the implant from the delivery system. Some embodiments may be configured for retraction of said implant from the patient&#39;s body following complete exteriorization of the implant from the delivery system. Some of the embodiments are directed at delivering a monofilament implant for preventing embolic stroke. Other embodiments are directed at preventing pulmonary embolism, occluding a body vessel such as the left atrial appendage, occluding a body passageway such as a patent foramen ovalae, stenting a body vessel, or releasing a local therapeutic agent such as a drug or ionizing radiation.

RELATED APPLICATIONS

The subject application claims priority to and benefit of U.S.provisional patent application No. 61/912,655, filed Dec. 6, 2013,entitled, “Systems and Methods for Implant”, the entire disclosure ofwhich is herein incorporated by reference.

FIELD OF THE DISCLOSURE

Embodiments of the present disclosure are directed generally to systemsand methods for delivering a monofilament implant to a body vessel of apatient.

BACKGROUND OF THE DISCLOSURE

PCT publication no. WO2013/179137 discloses various medical implants.Some of these implants comprise an un-deployed and a deployed state. Inthe un-deployed state, the implant is substantially linear, and in thedeployed state the implant assumes a shape directed at providing amedically beneficial function. The implants are typically made of superelastic alloy, such as nitinol. The implants disclosed in the patentdocuments mentioned above include embolic protection devices forpreventing brain stroke and pulmonary embolism, body vessel occlusiondevices, stents, and delivery platforms for therapeutic agents (forexample, drugs and ionizing radiation).

The implants are typically delivered via a thin needle and apusher/plunger configured to be slidably received within the lumen ofthe needle. Initially the implant is disposed in its un-deployed,substantially linear state near the distal end of the needle's lumen,and the pusher is disposed within the lumen proximally to the proximalend of the implant. In operation, the needle is directed by an operatorto a suitable implantation site, such as, for example, an artery or avein. Once the desired needle position is achieved, the pusher is usedto push the implant out of the distal end of the needle. As the implantis exteriorized it assumes its functional deployed shape inside thetarget vessel. Following complete exteriorization of the implant fromthe needle, the needle and the pusher are withdrawn from the patient'sbody, and the implantation procedure is complete.

Since the lumen of the delivery needle is typically of very smalldiameter (e.g., ranging from 0.05 to 0.5 mm), as well as the pusherdiameter being equally correspondingly small (e.g., also ranging from0.05 to 0.5 mm), the pusher may buckle under the push force required forpushing the implant out of the needle.

Since the operator typically uses ultrasound imaging to guide theimplantation procedure, the operator typically holds an ultrasound probein one hand and the delivery system in the other hand. As a result, theoperator may need another person in manipulating the delivery system.For example, the operator may need the help of another person inexteriorizing the implant by pushing the pusher. This complicates thedelivery procedure.

Moreover, it may be crucial that the implant be sized accordingly withrespect to at least one of its dimensions to specific sizes according tothe desired functionality. A sizing mistake may prevent the implant fromassuming a correct functional shape inside the vessel.

SUMMARY OF THE DISCLOSURE

In some embodiments, a system for delivering an implantable medicaldevice in a living body is provided, with the system comprising animplant having an un-deployed, substantially linear state and a deployedstate, a pusher comprising a push wire and a stabilizing tube rigidlyconnected together at their respective proximal ends, and a needlehaving a proximal and a distal end and a lumen there-between for housingsaid implant in an un-deployed state. The push wire may be configured tobe slidably received within the proximal end of the lumen of needle, andthe proximal end of the needle may be configured to be slidably receivedwithin the stabilizing tube.

In some such embodiments, such a system may also include one or more ofthe following features and/or functionality (various combinations ofwhich forming additional embodiments, even on their own):

-   -   the implant comprises a monofilament;    -   the stabilizing tube may be configured to maintain the push wire        substantially collinear with the lumen of the needle even if the        push wire buckles;    -   upon exteriorization from the needle, the implant may be        configured in a deployed state;    -   the implant includes a diameter between about 0.05 mm to about 1        mm;    -   the system of any of claims 1-5, wherein the needle includes an        outer diameter of between about 0.2 mm to about 2 mm;    -   the lumen of the needle includes a diameter between about 0.1 mm        to about 1.9 mm;    -   the lumen of the needle includes a diameter between about one to        about two times the diameter of the implant; and/or    -   the needle comprises a larger diameter echogenic needle and a        smaller diameter vessel-penetrating needle.

In some embodiments, a system for delivering an implantable medicaldevice in a living body is provided which comprises an implant having anun-deployed, substantially linear state and a deployed state, a pushercomprising a push wire, a first needle having a proximal and a distalend and a lumen there-between for housing said implant in an un-deployedstate, and a second needle having a proximal and a distal end and alumen there-between for housing said first needle. The second needle maybe configured to be received within the lumen of the first needle, andthe push wire may be configured to be slidably received within the lumenof the second needle.

In some such embodiments, such a system may also include one or more ofthe following features and/or functionality (various combinations ofwhich forming additional embodiments, even on their own):

-   -   the implant comprises a monofilament;    -   the first needle may be configured to be highly visible upon        ultra-sound imaging;    -   the second needle may be configured to penetrate the wall of a        body vessel;    -   the second needle may be slidable within the lumen of the first        needle;    -   the distal tip of the second needle protrudes a predetermined        distance distally to the distal end of the first needle, and the        predetermined distance may be greater than the thickness of a        target vessel wall;    -   the first needle and the second needle may be rigidly connected;    -   the first needle includes an outer diameter between about 0.3 mm        to about 1 mm;    -   the second needle includes an outer diameter between about 0.1        mm to about 0.8 mm;    -   the first needle may be configured with a diameter sufficient to        render it highly visible under ultrasound guidance;    -   in one or more of the needle, the first needle, and the second        needle the outer diameter at the distal end may be smaller than        the outer diameter at the proximal end;    -   in one or more of the needle, the first needle, and the second        needle the outer diameter may be configured to continuously        transition from a smaller distal end to a larger proximal end;    -   in one or more of the needle, the first needle, and the second        needle the outer diameter may be configured to transition from a        smaller distal end to a larger proximal end in a stepped        configuration;    -   in one or more of the needle, the first needle, and the second        needle may be configured with a rough surface;    -   in one or more of the needle, the first needle, and the second        needle may be configured with ultrasound reflection enhancement        means;    -   the reflection enhancement means comprises at least one of        cornerstone reflectors and an echogenic coating;    -   the echogenic coating comprises at least one micro-bubble;    -   the outer diameter of the second needle may be less than about        0.5 mm;    -   the outer diameter of the second needle may be less than about        0.3 mm;    -   the inner diameter of the second needle may be less than about        0.4 mm;    -   the inner diameter of the second needle may be less than about        0.25 mm;    -   a needle stabilizing tube including a lumen therein;    -   the lumen of the needle stabilizing tube may be configured to        receive the first needle;    -   the needle stabilizing tube may be rigidly joined to the second        needle;    -   the needle stabilizing tube may be rigidly joined to the second        needle at a predetermined point along the length of second        needle;    -   a handle disposed and rigidly connected to the second needle        proximate the p01tions of the needle and the stabilizing tube        which may be joined;    -   the outer diameter of the first needle may be between about 0.2        mm and about 1 mm;    -   the implant may be arranged in an un-deployed state adjacent the        distal end of the lumen of the second needle;    -   the push wire may be slidably received in the proximal end of        the lumen of the second needle;    -   a pusher stabilizing tube configured to slidably receive the        proximal end of the second needle at its distal end;    -   the second needle may be configured to be slidably received in        the proximal end of the lumen of the first needle;    -   the needle stabilizing tube slidably receives the proximal end        of the first needle; and/or    -   in an initial configuration, the distal tip of the second needle        may be arranged within the lumen of the first needle.

In some embodiments, a system for delivering an implant in a living bodymay be provided and comprises implant manipulation means, and a needle.In some such embodiments, such a system may also include one or more ofthe following features and/or functionality (various combinations ofwhich forming additional embodiments, even on their own):

-   -   an implant;    -   the implant comprises a monofilament;    -   the implant manipulation means comprises a pusher, a connector,        and a stopper;    -   the pusher comprises a wire;    -   the connector comprises a tube having a lumen configured to        provide a rigid, severable connection between implant and        pusher;    -   the stopper comprises a tube disposed near the distal end of the        lumen of needle;    -   the stopper includes a lumen and wherein the lumen of the        stopper may be configured as a truncated cone;    -   the stopper may be rigidly connected to the needle;    -   the stopper may be integral with the needle;    -   a distal end of the connector may be configured to receive a        proximal end of the implant;    -   the connector may be configured to receive at its proximal end        the distal end of pusher;    -   the connector may be configured to rigidly engage both the        proximal part of the implant and the distal part of the pusher;    -   rigid engagement comprises static friction;    -   the static friction force may be of sufficient strength to pull        the implant into the needle by pulling the pusher, without        severing the connection made by the connector between the        implant and the pusher;    -   the static friction force may be configured to enable the pusher        and the implant to slide through the lumen of the connector when        sufficient push-force may be applied to the pusher and the        connector may be kept motionless;    -   the static friction force may be configured via at least one of:        the connector being comprised of a heat-shrinkable plastic, and        optimizing at least one of the connector's length, initial        luminal diameter, and wall thickness;    -   both the pusher and the connector may be configured to be        slidably received within the lumen of the needle;    -   the implant may be configured to be slidably received in an        un-deployed state within the distal end of the lumen of the        needle;    -   the implant may be exteriorized by sliding the pusher within the        lumen of the needle until the distal end of the connector may be        in contact with the proximal end of the stopper;    -   the connector may be prevented from further advancing distally        in the lumen of the needle;    -   upon substantial exteriorization of the implant from the needle,        the pusher may be configured for continual pushing while the        needle may be held in place thereby releasing the implant from        the connector;    -   the connector may be engaged with the implant and/or the pusher        via at least one of one or more fasteners, a bayonet        configuration, and a positive locking mechanism;    -   the implant manipulation means comprises a pusher comprising an        electrically conducting core and an insulating coating, and the        connector comprising an insulator, wherein an area of the        conducting cores Jacks the insulating coating such that electric    -   current may be applied in the core thereby electrolyzing the        conductor in the vicinity of the area;    -   the system may be configured to recapture a partially        exteriorized implant by pulling the manipulation means with        respect to the needle;    -   the implant manipulation means comprises at least one of a push        tube, and a disengagement wire;    -   a wire handle;    -   the disengagement wire may be configured to be slidably received        within a proximal end of the lumen of the push tube;    -   the implant manipulation means may be configured to be slidably        received within a proximal end of the lumen of the needle;    -   the implant may be configured to be slidably received in an        un-deployed state within a distal end of a lumen of the needle;    -   a distal end of the push tube mechanically engages a proximal        end of the implant;    -   a proximal end of the implant may be inserted in a distal end of        a lumen of the push tube, and the connection may be held        together by static friction;    -   the implant may be exteriorized by sliding the implant        manipulation means within the lumen of the needle;    -   the system may be configured to recapture a partially        exteriorized implant by pulling the manipulation means with        respect to the needle;    -   the implant may be configured to be disengaged from the implant        manipulation means; and/or    -   disengagement comprises pushing the stopper distally until        contact with the proximal end of the needle, then pushing        disengagement wire distally, thereby exteriorizing the proximal        end of the implant from the distal end of the lumen of the push        tube;

In some embodiments, a system for delivering an implant in a living bodyis provided and comprises a driving mechanism, a pusher, and a needle.In some such embodiments, such a system may also include one or more ofthe following features and/or functionality (various combinations ofwhich forming additional embodiments, even on their own):

-   -   an implant;    -   the pusher comprises a push wire and a rack;    -   a stabilizing tube;    -   the rack may be joined to the stabilizing tube on an outside        wall thereof;    -   the rack may be collinear with the stabilizing tube;    -   the rack assumes the shape of a toothed strip;    -   the rack may be cylindrically symmetrical;    -   the driving mechanism comprises a motor having a motor axis and        a spur gear rotated by the motor axis;    -   the motor axis may be substantially perpendicular to the needle;    -   the rack may be configured to engage with a spur gear via        interlocking of teeth of the rack with teeth of the spur gear,        and rotation of the spur gear causes the pusher to move relative        to the needle;    -   input means for controlling the rotation of the motor;    -   the driving mechanism comprises a motor, a worm gear, and        optionally a spur gear, where the worm gear comprises helical        threads configured to engage the teeth of the rack or the spur        gear;    -   the spur gear may be disposed between the worm gear and the        rack, the threads of the worm gear may be configured to engage        teeth of the spur gear, and the teeth of the spur gear may be        configured to engage teeth of the rack;    -   the axis of rotation of the worm gear correspond with the motor        axis;    -   the motor axis may be substantially parallel to the needle.    -   one or more of a controller, a CPU, a computer memory, a        man-machine interface, and a power supply;    -   the rack may be configured to engage with the worm gear via        interlocking of the teeth of the rack with the threads of the        worm gear or via interlocking of the teeth of the rack with the        teeth of a spur gear and interlocking the teeth of the spur gear        with the threads of the worm gear, where rotation of the worm        gear causes the pusher to move relative to the needle;    -   the driving mechanism may be rigidly joined to the needle;    -   the driving mechanism comprises a motor coupled to a first        roller and a second roller, wherein the motor causes the first        roller to rotate;    -   the push wire may be disposed between the first and the second        roller; and/or    -   the force of friction between the first roller and the push wire        causes the push wire to advance or retract as a result of roller        rotation by the motor.

In some embodiments, a method of delivering an implant in a living bodymay be provided and comprises providing a system according to any systemembodiment supported by the present disclosure, determining the diameterof a target vessel at an implantation site, selecting an appropriatesized implant for the target vessel based on the determined diameter ofthe target vessel, penetrating the skin adjacent the target vessel via atip of the needle, advancing the tip of the needle towards the targetvessel, penetrating the target vessel using the tip of needle, advancingthe pusher toward the distal end of the needle, and withdrawing theneedle and the pusher out of the target vessel.

In some such embodiments, such a method may also include one or more ofthe following features and/or functionality (various combinations ofwhich forming additional embodiments, even on their own):

-   -   upon the implant comprising a stem, the pusher may be configured        such that the distance between the distal tip of the pusher and        the distal end of the needle may be approximately equal to the        length of the stem, resulting in the implant assuming a correct        position within the target vessel;    -   the method may be performed under imaging guidance comprising at        least one of ultrasound, high resolution ultrasound, x-ray        fluoroscopy, CT, and MRI;    -   advancing comprises placing a tip of the needle a predetermined        distance from the vessel puncture site;    -   the implant assumes a predetermined orientation after        exteriorization;    -   upon the implant being an embolic protection device, a tip of        the needle may be placed about 1 mm into the lumen of the target        vessel;    -   the needle assumes an approximately perpendicular orientation        with respect to a plane tangent to the arterial wall at the        puncture site;    -   the implant may be preloaded in the system;    -   selection of the implant comprises selecting the maximal        diameter of the deployed state of the implant may be between        about 0.5 to about 1 mm less than the diameter of the vessel;    -   selecting of the appropriately sized implant comprises        under-sizing the implant along at least one dimension of the        implant relative to the diameter of the target vessel;    -   and/or    -   oversizing the implant along another dimension of the implant        relative to the diameter of the target vessel.

In some embodiments, a system for delivering an implant in a living bodyis provided and comprises an implant, a needle, a pusher, a connectorconfigured to reversibly attach the implant and the pusher, the implantmay be exteriorized from the needle by pushing the pusher, the implantmay be interiorized in the needle by pulling the pusher, and the implantmay be disconnected from the connector by pushing the pusher.

In some embodiments, a removable implant system is provided andcomprises a pusher, a removable implant comprising a monofilament and apull-wire, wherein the pull wire is affixed to or integral with an endof the monofilament and configured to extend outside the body of apatient a predetermined distance when the implant is implanted to enablethe implant to be pulled out of the vessel, and wherein the implantincludes a un-deployed and a deployed stat, and a needle. The pushercomprises a hollow tube having a lumen.

In some embodiments, a removable implant configured for placement withina target vessel of a patient is provided, where the implant comprises amonofilament and a pull-wire. The pull wire is affixed to or integralwith an end of the monofilament and configured to extend outside thebody of a patient a predetermined distance when the implant is implantedto enable the implant to be pulled out of the vessel, and wherein theimplant includes an un-deployed and a deployed state.

In some embodiments, the implant may include one or more of thefollowing:

-   -   an anchor;    -   the pull-wire is affixed at one end to the filament via at least        one of welding, brazing, gluing, or by means of a mechanical        connector;    -   the monofilament and/or pull-wire are affixed to the anchor via        at least one of welding, brazing, gluing, or crimping;    -   at least a portion of the monofilament in the deployed state        includes a substantially straight stem configured to traverse a        wall of a target vessel, where the stem may be configured to        secure the implant in place;    -   in the deployed state, the implant further comprises a        functional portion configured in the shape of a helix, where the        helix traces a shape corresponding to a shell of a body of        revolution which may include a sphere, an oval, or an ellipsoid,        and upon implantation, the axis of the helix may be configured        approximately perpendicular to the direction of the vessel;        additionally, the length of the helix may be configured to be        greater than the diameter of the target vessel, and the diameter        of the helix is less than the diameter of the target vessel;    -   an anchor configured to reside near the proximal end of the stem        (see above feature), where the anchor includes an un-deployed        state configured to fit within the lumen of a delivery needle,        and a deployed state configured to adhere to surrounding tissue,        and the anchor may comprise one or more barb, one or more        protrusion, or one or more micro-barb;    -   the pull-wire includes a circular cross section with a diameter        of between about 0.03 mm and 1.0 mm;    -   the needle comprises metal or plastic, and an outer diameter of        the needle ranges between about 0.2 mm to about 2 mm, and/or an        inner diameter of the needle ranges between 0.1 mm to 1.9 mm;    -   the pull-wire is configured such that at least a portion thereof        is slidably fits within lumen of the pusher;    -   the pusher is configured to slidably fit within the lumen of the        needle;    -   the monofilament includes an anchor, and the pusher is        configured to push either on the proximal end of the        monofilament or on a proximal end of the anchor; and/or    -   the pusher is initially arranged in a proximal end of the lumen        of the needle, proximally to the monofilament and the anchor,        with at least a portion of the pull-wire arranged within the        lumen of the pusher.

In some embodiments, a method of implanting the monofilament implantaccording to any of the disclosed implant embodiments using any of thesystem embodiments disclosed herein is provided and may comprise atleast one of the following steps, and in some embodiments, several ofthe following steps, and in some embodiments, substantially all of thefollowing steps: assessing the size of a target vessel via at least oneof ultrasound, fluoroscopy, CT, or MRI, upon the vessel being an arteryor a vein, a systolic or minimal diameter at the implantation site ismeasured and recorded, selecting an appropriately sized implant, whereat least a portion of the implant is configured as a helix whendeployed, the helix diameter being between 0.1 mm and 1.0 mm compared tothe minimal vessel diameter at the implantation site, wherein theselected implant is preloaded within one or another of the disclosedsystem embodiments, puncturing the skin of the patient, advancing a tipof the needle towards the target vessel, puncturing the wall of thetarget vessel using the tip of the needle, placing the tip in the lumenof the target vessel approximately in the middle of the lumen of thevessel, where the needle may assume an approximately perpendicularorientation with respect to a plane tangent to the vessel wall at thepuncture site, advancing the pusher towards the distal end of theneedle, resulting in the implant being exteriorized from the needle,where the exteriorized portion of the implant is configured to resumethe deployed shape. The method may further include one or more offurther advancing the pusher until its proximal end is aligned with theproximal end of the needle, verifying proper positioning and/or shape ofthe deployed monofilament within the target vessel lumen, andwithdrawing the needle and the pusher.

The method embodiments may further include one or more of the followingsteps and/or functionality (for the method, system and/or implant):

-   -   the implant further comprises an anchor, and the anchor slides        out of the tip of the needle as the needle is being pulled, and        the pull-wire slides out of the pusher lumen;    -   the implant further comprises a stem portion, and upon complete        withdrawal of the needle and the pusher, a functional portion of        the monofilament is arranged within the lumen of the target        vessel, the stem traverses the vessel wall, the anchor is        arranged external to the vessel wall and under the skin, and/or        the pull-wire traverses the patient's skin;    -   inspecting the implantation area for proper positioning and/or        deployment of the implant using a suitable imaging modality        using at least one of ultrasound, x-ray, fluoroscopy, MRI or CT;    -   upon a permanent implantation, and upon proper positioning        and/or deployment of the implant, clipping the pull-wire at the        level of skin, and lifting the skin thereafter to arrange the        remainder of the pull-wire subcutaneously;    -   upon the implant intended for removal due to temporary nature of        use, or for removal due to safety concerns, pulling the pull        wire to cause the monofilament to deform for exteriorization        from the target vessel and from the patient's body;    -   the system further including a motor configured to advance the        pusher, for effecting advancement of the pusher via a gear        and/or a rack.

Advantages of Some Embodiments of the Disclosure

Some embodiments according to the present disclosure have severalimportant advantages over prior art.

Some embodiments may be more reliable because the deleterious effects ofpusher buckling may be diminished.

Some embodiments may be safer to use because they enable removal of theimplant from the patient's body following complete (satisfactory orunsatisfactory) exteriorization from the delivery system.

Some embodiments may be safer because they enable the implant to beinteriorized into the delivery system following partial (or evennear-complete) unsatisfactory exteriorization.

Some embodiments may be safer because they allow for better needlevisualization by ultrasound.

Some embodiments may be safer because they eliminate the tradeoffbetween needle visibility under ultrasound and a small vessel wallpuncture size.

Some embodiments enable a single-operator ultrasound-guided procedurebecause they are automatic.

Some embodiments may be easier to use because they are automatic.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be better understood with reference to theaccompanying drawings and subsequently provided detailed description:

FIGS. 1A-E depict an implant system and its corresponding method of useaccording to some embodiments of the present disclosure. The systemcomprises a pusher that configured to diminish the effect of buckling.

FIG. 2A-C depict various needle designs according, to some embodimentsof the present disclosure. These designs render the needle more visibleunder ultrasound imaging and less traumatic to the target vessel.

FIGS. 3A-F depict an implant system and its corresponding method of useaccording to some embodiments of the present disclosure. The systemcomprises a first introducer needle and a second, vessel-puncturingneedle that is slidable within the introducer needle lumen.

FIGS. 4A-E depict an implant system according to some embodiments of thepresent disclosure. Under certain conditions the system allows forinteriorization of the implant back into the needle lumen.

FIGS. 5A-D depict an implant system according to some embodiments of thepresent disclosure. The system features mechanical engagement anddisengagement of the implant and the pusher.

FIGS. 6A-C depict an automatic delivery system comprising a motoraccording to some embodiments of the present disclosure. The motor axisis approximately perpendicular to the needle.

FIGS. 7A-C depict an automatic delivery system comprising a motoraccording to some embodiments of the present disclosure. The motor axisis approximately parallel to the needle.

FIGS. 8A-C depict an automatic delivery system in which power istransmitted from a motor to a push wire via rollers.

FIGS. 9A-H depict a removable implant system and its correspondingmethod of use according to some embodiments of the present disclosure.

DETAILED DESCRIPTION OF SOME OF THE EMBODIMENTS

Reference is now made to FIGS. 1A-E, which depict an implant system andmethod for implant delivery according to some embodiments of the presentdisclosure. System 1 may comprise a pusher 10, an implant 12, and aneedle 11. Pusher 10 may comprise a push wire 14 and a stabilizing tube13.

The push wire and the stabilizing tube may be rigidly connected at theirproximal ends by a suitable method such as, for example, welding,gluing, or screwing. Push wire 14 is configured to be slidably receivedwithin the proximal end of the lumen of needle 11. Stabilizing tube 13is configured to slidably receive the proximal end of needle 11.

Stabilizing tube 13 diminishes the deleterious effect of buckling ofwire 14 as it is being pushed into the lumen of needle II. This isbecause stabilizing tube 13 may be made sufficiently stiff as to notbuckle under the push force required to slide implant 12 within thelumen of needle 11, and push wire 14, even if it buckles, is kept by theinternal walls of stabilizing tube 13 substantially collinear with thelumen of needle 11. Push wire 13 is thus able to transmit push forcefrom its proximal to its distal end even if it buckles.

Push wire 14 may be made from metal or plastic. Suitable metals include,for example, stainless steel and nitinol. Stabilizing tube 13 may alsobe made from metal or a plastic. Suitable metals include, for example,stainless steel and nitinol.

Implant 12 may be made from a super elastic alloy, such as nitinol. Theimplant may be of monofilament construction (as depicted in in FIG. 1A),but may also may be of a different construction (for example, amulti-filament construction or a cut-tube construction). The implantassumes an un-deployed, substantially linear state (as in FIG. 1A) or adeployed, functional state (as in FIG. 1E). The implant is constrainedto its un-deployed substantially linear state by the needle, in whosedistal lumen end it initially resides. Upon exteriorization from theneedle (FIGS. 1C-1E), the implant retains its deployed, functional stateby virtue of its super-elasticity.

Whenever implant 12 is a monofilament implant, the wire from which it ismade may have a circular cross-section. The diameter may range fromabout 0.05 mm to about 1 mm.

Implant 12 may be an embolic protection device for stroke prevention, anembolic protection device for pulmonary embolism prevention, a vesselocclusion device such as a left atrial appendage occluder, a therapeuticagent delivery platform a stent, or any other medical implant that fitsin its un-deployed state into the lumen of a thin needle. Implant 12 maybe any implant that can be twisted into its functional shape from amonofilament. Implant 12 may be, but is not limited to, any of theimplants described in U.S. Provisional Patent Applications Nos.61/653,676, 61/693,979, 61/746,423, 61/754,264, as well as PCTpublication nos. WO2013/179137, WO2014/102767 and WO2014/111911 (theentire disclosures of which all herein incorporated by reference).

In some embodiments, the functional, deployed state of implant 12 maycomprise a substantially straight stem 17, configured to traverse thewall of a target vessel 16 and anchor the implant in place, and afunctional portion 18, configured to perform a beneficial medicalfunction (FIG. 1E). If, for example, implant 12 is an embolic protectiondevice then functional portion 18 resembles the shape of a helix. Thehelix is implanted with its axis perpendicular to the blood flow in thevessel, and (sufficiently large) emboli originating upstream of theimplant may be prevented by the helix coils from flowing past theimplant. The helix of monofilament embolic protection devices accordingto some embodiments may be configured to trace the shape of a cone or anhour glass. Such devices may have a stem intended for traversing avessel wall. The stem may be perpendicular to the helix axis.

Needle 11 may be made from metal or plastic. Suitable metals include,for example, stainless steel and nitinol. The outer diameter of theneedle may range from about 0.2 mm to 2 mm. The inner diameter of theneedle may range from 0.1 mm to 1.9 mm.

Whenever implant 12 is a monofilament implant, the inner diameter ofneedle 11 may be between one and two times the diameter of the wire fromwhich implant 12 is made. We have found in laboratory experiments thatthis minimizes the push force required to insert and/or advance implant12 in the lumen of needle 11.

In operation, the operator first assesses the size of target vessel 16.Typically, the assessment is made by, for example, ultrasound,fluoroscopy, CT, or MRI. If, for example, the vessel is an artery or avein, the systolic (minimal) diameter of the vessel at the implantationsite is measured and recorded. The operator then chooses anappropriately sized implant 12 (preloaded in system 1). Whenever implant12 is a monofilament implant, the operator chooses the implant sizeaccording to the following rule: the maximal diameter of the deployedstate of the implant should be about 0.5 to 1.5 mm less than thesystolic diameter of the vessel. In some embodiments under-sizing may berequired in order to allow for the implant to properly exteriorize andassume its functional, deployed shape.

Next, the operator punctures skin 15, advances the tip of needle 11towards the target vessel 16, and punctures target vessel 16 using thetip of needle 11 (FIG. I B). All of these steps may be performed underimaging guidance. Possible imaging modalities include ultrasound, highresolution ultrasound, x-ray fluoroscopy, CT, and MRI. The tip is placeda predetermined distance from the vessel puncture site, and the needleassumes a predetermined orientation. For example, if implant 12 is anembolic protection device, then the tip of needle 11 is placed about 1mm into the lumen of vessel 16. The needle assumes a perpendicularorientation with respect to a plane tangent to the arterial wall at thepuncture site. Whenever the operator determines that either the tip isplaced improperly or the needle orientation is improper, system 1 may beretracted and the present step of the procedure may be attempted again.

Once proper needle position has been achieved, the operator holds needle11 steady and advances pusher 10 towards the distal end of the needle(FIG. 1 C). This causes implant 12 to be exteriorized from the needle.The exteriorized portion of the implant attempts to assume itsfunctional deployed shape.

The operator continues to push pusher 10 until its proximal end touchesthe proximal end of needle 11. Whenever implant 12 comprises a stem 17pusher 10 may be configured such that at the position described in FIG.1D the distance between the distal tip of the pusher and the end of theneedle is approximately equal to the length of the stem. In someembodiments, this enables the implant 12 to assume the correctorientation within the vessel.

Next, the operator verifies using an appropriate imaging modality thatthe implant is properly positioned and withdraws the needle and thepusher out of the patient's body (FIG. 1E). The implantation procedureis complete.

Reference is now made to FIGS. 2A-C, which depict various designsaccording to some embodiments of needle 11 of system 1. Needle 11 neednot be of uniform outer diameter. Furthermore, needle 11 need not be ofmonoblock construction. For example, needle 11 may comprise a firstlarger diameter needle 21 and a second smaller diametervessel-puncturing needle 22 (FIG. 2A). The second needle 22 is housedwithin the lumen of the first needle 21. The distal tip of second needle22 protrudes a predetermined distance distally to the distal end offirst needle 21. This distance is typically somewhat larger than thethickness of the target vessel wall. The two needles may be connectedusing a suitable means such as, for example, gluing, or welding. Firstneedle 21 may have an outer diameter ranging from about 0.3 mm to about1 mm, and second needle 22 may have an outer diameter ranging from about0.1 mm to about 0.8 mm. First needle 21 may be made out of metal, suchas, for example, stainless steel or nitinol. The same goes for secondneedle 22.

In operation, the operator may use ultrasound guidance to advance theneedle of FIG. 2A towards the target vessel. As the first needle 21 isclearly visible (whereas the tip of second needle 22 need not beultrasound visible), the operator punctures the vessel wall by advancingthe tip of the first needle adjacent to the vessel wall. The secondneedle 22, whose sharp distal end protrudes beyond the distal end offirst needle 21, thus penetrates the vessel wall.

The embodiment of needle 11 depicted in FIG. 2A has the followingadvantages: (I) safety: the second needle may have a very small outerdiameter, thereby causing minimal reducing trauma to the vessel wall.For example, the outer diameter of second needle 22 may be less than 0.5mm, or even less than 0.3 mm. (2) The first needle may have a diametersufficient to render it highly visible under ultrasound guidance. Forexample, the diameter of the first needle 21 may be greater than 0.5 mm,or even greater than 0.8 mm; (3) The first needle 21 may have an outerdiameter sufficiently large as to make needle 11 sufficiently stiff topenetrate towards structures deep in the patient's body. Thus, theembodiment of needle 11 according to FIG. 2A eliminates the inherenttradeoff existing in uniform-outer-diameter needles: ultrasoundvisibility and stiffness on the one hand against a small outer diameterfacilitating minimally-traumatic punctures.

Reference is now made to FIGS. 2B and 2C, which depict some embodimentsof needle 11 according to the present disclosure. In both cases theouter diameter of the distal end of the needle is smaller than the outerdiameter of the proximal end of the needle. In FIG. 2B the transitionfrom the smaller to the larger outer diameter is continuous, whereas inFIG. 2C it is discontinuous (that is, a step or a multi-steptransition). The operation of systems I comprising the needles 11according to FIGS. 2B and 2C is similar to the operation of systemsbased on the needle of FIG. 2A, and will therefore be omitted. Theadvantages of the needles II according to FIGS. 2B and 2C are alsoessentially the same as for the needle of FIG. 2A. The needles of FIG.2B-C may be made out of metal, such as, for example, stainless steel ornitinol. The needles may be given their shapes by, for example,machining.

The needles of FIGS. 2A-C may be made echogenic by roughening theirsurfaces, providing them with ultrasound reflection enhancement means,such as cornerstone reflectors, or coating them with echogenic coatingssuch as a micro-bubble-containing polymer coating.

Reference is now made to FIGS. 3A-F, which depict an implant system anda method for implant delivery according to some embodiments of thepresent disclosure. System 3 may comprise an implant 12, a firstechogenic needle 35, a second needle 36, and a pusher 31.

Implant 12, which may (but does not have to be) a monofilament implant,is substantially similar to the implant of system 1, and therefore itsdetailed description will be omitted here.

Second needle 36 may be made, for example, from plastic or metal.Suitable metals include, for example, stainless steel and nitinol. Theouter diameter of second needle may be less than about 0.5 mm, or evenless than about 0.3 mm. The inner diameter of second needle may be lessthan about 0.4 mm, or even less than 0.25 mm. Optionally, a needlestabilizing tube 38 may be configured to receive first needle 35 in itslumen. Tube 38 may be rigidly joined to second needle 36 at apredetermined point along the length of second needle 36. Optionally, ahandle 37 may be disposed and rigidly connected to second needle 36 atthe vicinity of the point where needle 36 and tube 38 are joined.

First needle 35 may be made, for example, from plastic or metal.Suitable metals include, for example, stainless steel and nitinol. Theouter diameter of first needle 35 may range from about 0.2 mm to about 1mm.

Pusher 31 may have a similar construction to pusher 13 of system 1:pusher 13 may comprise a push wire 34 and optionally a pusherstabilizing tube 33, which may be joined at their proximal ends.Optionally, pusher 31 may comprise a pusher handle 32.

Initially (FIG. 3A), implant 12 situated in the un-deployed state nearthe distal end of the lumen of second needle 36. Push wire 34 isslidably received in the proximal end of the lumen of second needle 36.Stabilizing pusher tube 33 slidably receives at its distal end theproximal end of second needle 36. Second needle 36 is slidably receivedin the proximal end of the lumen of first needle 35. Needle stabilizingtube 38 slidably receives the proximal end of first needle 35.Initially, the distal tip of second needle 36 is within the lumen offirst needle 35.

In operation, the operator first assesses the size of target vessel 16.Typically, the assessment is made by, for example, ultrasound,fluoroscopy, CT, or MRI. If, for example, whenever the vessel is anartery or a vein, the systolic (minimal) diameter of the vessel at theimplantation site is measured and recorded. The operator then chooses anappropriately sized implant 12 (preloaded in system 3). Whenever implant12 is a monofilament implant the operator may choose the size accordingto the following rule: the maximal diameter of the deployed state of theimplant should be about 0.5 to 1 mm less than the systolic diameter ofthe vessel. Undersizing is required in order to allow for the implant toproperly exteriorize and assume its functional, deployed shape.

Next, the operator punctures skin 15 using the tip of first needle 35and advances the tip of needle 35 towards the target vessel 16 (FIG.3B). All of these steps may be performed under imaging guidance.Possible imaging modalities include ultrasound, high resolutionultrasound, x-ray fluoroscopy, CT, and MRI. The tip of first needle 35is placed a predetermined distance from the vessel puncture site, andthe needle assumes a predetermined orientation. For example, if implant12 is an embolic protection device, then the tip of needle 35 is placedabout 1 mm outside of the wall of vessel 16. The needle assumes aperpendicular orientation with respect to a plane tangent to thearterial wall at the puncture site. Whenever the operator determinesthat either the tip is placed improperly or the needle orientation isimproper, system 3 may be retracted and the present step of theprocedure may be attempted again.

Once proper needle position has been achieved, the operator holds needle35 steady and advances handle 37 towards the distal end of needle 35(FIG. 3C). This causes second needle 36 to exteriorize from the lumen offirst needle 35 and puncture the vessel wall. The pushing of handle 37ceases when the proximal end of first needle 35 reaches handle 37 (and,optionally, the proximal end of stabilizing tube 38, which prevents thebucking of needle 36).

Next, the operator holds needles 35 and 36 steady and advances pusher 31towards the distal end of needle 36 (FIG. 3D). This causes implant 12 tobe exteriorized from the needle. The exteriorized portion of the needleattempts to assume its functional shape.

The operator continues to push pusher 31 until its proximal end touchesthe proximal end of second needle 36. Whenever implant 12 comprises astem 17 pusher 31 may be configured such that at the position depictedin FIG. 3E the distance between the distal tip of the push wire 34 andthe end of needle 36 is approximately equal to the length of the stem.This enables the implant 12 to assume the correct orientation within thevessel.

Next, the operator verifies using an appropriate imaging modality thatthe implant is properly positioned and withdraws the needles and thepusher out of the patient's body (FIG. 3F). The implantation procedureis complete.

An embodiment of system 3 lacking implant 12 and in which second needle36 is configured as a biopsy needle is possible.

System 3 has the following important advantages: (1) ease of use:initially, the tip of the second needle is inside the lumen of the firstneedle. Therefore confusion between the tips of the two needles uponultrasound visualization is eliminated; (2) safety: the second needlemay have a very small outer diameter, thereby making the puncture in thevessel wall correspondingly small and non-traumatic; (3) theneedle-in-needle configuration provides desired stiffness during systeminsertion.

Reference is now made to FIGS. 4A-E, which depict an implant systemaccording to some embodiments of the present disclosure. System 4 maycomprise an implant 12, implant manipulation means 40, and a needle 43.

Implant 12, which may (but does not have to) be a monofilament implant,is substantially similar to the implant of systems 1 and 3. Needle 43may be substantially similar to needle 11 of system 1. Therefore adetailed description of implant 12 and needle 43 is omitted.

Implant manipulation means 40 may comprise a pusher 41, a connector 42,and a stopper 44.

Pusher 41 may be substantially similar to pusher 10 or to push wire 14of system 1.

Connector 42 may be configured as a tube having a lumen, whose functionis to provide a rigid yet severable connection between implant 12 andpusher 41. The connector may be made, for example, from metal, plastic,or heat-shrinkable plastic.

Stopper 44 may be a tube disposed near the distal end of the lumen ofneedle 43. The lumen of stopper 44 may be of uniform diameter, or itmight have a varying diameter. The lumen of stopper 44 may have theshape of a cone with the apex cut off. Stopper 44 may be made frommetal. The stopper may be rigidly connected to the needle by, forexample, welding, soldering, or brazing. Stopper 44 may be integral withneedle 43. Whenever the stopper is integral with the needle it may bemade by, for example, machining the needle.

Connector 42 may be configured to receive at its distal end the proximalend of implant 12. Connector 42 may also be configured to receive at itsproximal end the distal end of pusher 41. The connector may beconfigured to rigidly engage both the proximal part of implant 12 andthe distal part of pusher 41 by static friction. The static frictionforce may be configured sufficiently large such that pulling the implantinto the needle (by pulling the pusher) is possible without severing theconnection made by connector 42 between implant 12 and pusher 41. Thestatic friction force may also be simultaneously configured to besufficiently small as to enable the pusher and implant to slide throughthe lumen of the connector when sufficient push-force is applied to thepusher and the connector is kept motionless.

Providing appropriate static friction force may be achieved by one ormore of making the connector from heat-shrinkable plastic and optimizingthe connector's length, initial luminal diameter, and wall thickness.

Both pusher 41 and engagement mechanism 42 may be configured to beslidably received within the lumen of needle 43. Implant 12 isconfigured to be slidably received in its un-deployed state within thedistal end of the lumen of needle 43.

Implant 12 is exteriorized by sliding pusher 41 within the lumen ofneedle 43 until the distal end of connector 42 is in contact with theproximal end of stopper 44 (FIG. 4B). The connector is thus preventedfrom further advancing distally in the lumen of needle 43. When theimplant is in the position depicted in FIG. 4B, it is possible toexteriorize the implant completely by continuing to push the pusher. Thecontinued pushing causes the pusher to slide within the lumen ofconnector 42, thereby overcoming the friction force between connector 42and implant 12, thus pushing the proximal part of implant 12 out of thelumen of the connector (FIG. 40). Needle 43 and manipulation means 40may then be retracted, leaving behind implant 12 in the deployed state(FIG. 4E).

It is also possible interiorize a partially exteriorized implant 12 bypulling the pusher with respect to needle 43. The pull force istransmitted to implant 12 via the static friction force betweenconnector 42 and both of implant 12 and pusher 41 (FIG. 4C).

The operation of system 4 is substantially similar to the operation ofsystem 1, except for the following step. Following near-completeexteriorization (FIG. 4B) of the implant from the needle, the operatorverifies using a suitable imaging modality that the implant is properlydeployed in the target vessel. If this is the case then the operatorcontinues to push the pusher while holding the needle in place, therebyreleasing the implant from the connector (FIG. 40) and withdraws fromthe patient's body all non-implantable elements of the system (FIG. 4E).Otherwise, the operator holds needle 43 steady and pulls pusher 41 back,thereby interiorizing implant 12 into the needle lumen. The operator maythen attempt the procedure once more.

It is possible for connector 42 to engage implant 12 and/or pusher 41 byany mechanical means known in the art. Suitable mechanical means mayinclude, screwing, a bayonet, and a positive locking mechanism. It ispossible to make the pusher from an electricity conducting core and aninsulating coating. The connector may also be made from an insulator. Anick may be made in the insulating coating of the pusher. Electriccurrent may be run in the core, thereby electrolyzing the conductor inthe vicinity of the nick. This mechanism, similar to the detachmentmechanism of embolization coils, may be used to detach the implant andthe connector from the pusher.

In some embodiments, stopper 44 may be optional.

Reference is now made to FIGS. 5A-D, which depict an implant systemaccording to some embodiments of the present disclosure. System 5 maycomprise an implant 12, an implant manipulation means 51, a needle 56,and a stopper 54.

Implant 12, which may (but does not have to) be a monofilament implant,may be substantially similar to the implant of systems 1 and 3. Needle56 may be substantially similar to needle 11 of system 1. Therefore adetailed description of implant 12 and needle 56 is omitted.

Implant manipulation means 51 may comprise a push tube 52, adisengagement wire 53, and, optionally, wire handle 55. Disengagementwire is configured to be slidably received thin (the proximal end of)the lumen of push tube 52.

Implant manipulation means 51 is configured to be slidably receivedwithin the proximal end of the lumen of needle 56. Implant 12 isconfigured to be slidably received in its un-deployed state within thedistal end of the lumen of needle 56.

The distal end of push tube 52 mechanically engages the proximal end ofimplant 12: the proximal end of implant 12 is inserted in the distal endof the lumen of push tube 52. The connection is held together by staticfriction.

Implant 12 is exteriorized by sliding implant manipulation means 51within the lumen of needle 56 (FIG. 5B). It is also possible interiorizea partially exteriorized implant 12 by pulling the manipulation meanswith respect to needle 56.

Implant 12 may be disengaged from implant manipulation means 51 in thefollowing way: The stopper 54 is pushed distally until it contacts theproximal end of needle 56. This causes the disengagement wire to bepushed distally, thereby exteriorizing the proximal end of implant 12from the distal end of the lumen of push tube 52.

The operation of system 5 is substantially similar to the operation ofsystem 1, except for the following step. Following near-completeexteriorization of the implant from the needle, wherein the proximal endof implant 12 is engaged with the distal end of push tube 52 and thestopper 54 is in contact with the proximal end of needle 56 (FIG. SB),the operator verifies using a suitable imaging modality that the implantis properly deployed in the target vessel. If this is the case then theoperator pushes the disengagement wire handle distally and therebydisengages the implant from the push tube (FIG. 5C). Then the operatorwithdraws from the patient's body all non-implantable elements of thesystem. Otherwise, the operator holds needle 56 steady and pulls pusher51 back, thereby interiorizing implant 12 into the needle lumen. Theoperator may then attempt the procedure once more.

The systems according to the embodiment presented in FIGS. 4A-E and 5A-Dhave the advantage of improved safety: an improperly exteriorizedimplant may be withdrawn back into the needle, thereby obviating theneed to extract a mal-deployed implant using minimally invasive or evensurgical means.

Reference is now made to FIGS. 6A-C, which depict an automatic implantsystem according to some embodiments of the present disclosure.Automatic implant system 6 may comprise an implant 12, a drivingmechanism 61, a pusher 64, and a needle 68. Implant 12, which may (butdoes not have to) be a monofilament implant, may be substantiallysimilar to the implant of systems 1 and 3. Needle 68 may besubstantially similar to needle 11 of system 1. Therefore a detaileddescription of implant 12 and needle 68 is omitted.

Pusher 64 may comprise push wire 65, stabilizing tube 67, and rack 66.Push wire 65 is substantially similar to push wire 14 of system 1, andstabilizing tube 67 is substantially similar to stabilizing tube 13 ofsystem 1. The push wire and the stabilizing tube may be rigidly joinedat their proximal end using a suitable joining technique (for example,gluing, welding, or soldering). Rack 66 is joined to stabilizing tube 65on its outside wall. Rack 66 may be collinear with stabilizing tube 65as in FIG. 6A. The rack may assume the shape of a toothed strip. It mayalso be cylindrically symmetrical. The rack may be integral with thestabilizing tube, or it may be separate from it.

Driving mechanism 61 may comprise a motor 62 and a spur gear 63, whichis rotated by the motor axis. The motor axis is substantiallyperpendicular to the needle. Driving mechanism 61 may be rigidly joinedto needle 68. Driving mechanism 61 may also comprise one or more of acontroller, a CPU, a computer memory, a man-machine interface, and apower supply (all not shown).

Initially, implant 12 is loaded in its un-deployed shape in the distallumen of needle 68. Push wire 65 of pusher 64 is slidably received inthe proximal end of the lumen of needle 68. The distal end ofstabilizing tube 67 slidably receives the proximal end of needle 68.Rack 66 is configured to engage with spur gear 63 via interlocking ofthe teeth of the rack with the teeth of the spur wheel. Thus, rotationof the spur wheel causes pusher 64 to move relative to needle 68.

The operation of system 6 is substantially similar to the operation ofsystem 1 except for the following difference: instead of manuallypushing the pusher in order to exteriorize implant 12 from needle 68,the operator causes pusher 66 to exteriorize the implant by providinginstructions (via, for example, buttons comprised in the man machineinterface) to driving mechanism 61.

System 6 has the following important advantages: (1) it enables single”handed operation by a single operator, and; (2) In reducesinter-operator variability because of automation.

Reference is now made to FIGS. 7A-C, which depict an automatic implantsystem according to some embodiments of the present disclosure.Automatic implant system 7 may comprise an implant 12, a drivingmechanism 71, a pusher 75, and a needle 79.

Implant 12, which may (but does not have to) be a monofilament implant,may be substantially similar to the implant of systems 1 and 3. Needle79 may be substantially similar to needle 11 of system 1. Therefore thedetailed description of implant 12 and needle 79 is omitted.

Pusher 75 is substantially similar to pusher 64 of system 6. Push wire77, stabilizing tube 78, and rack 76 may be substantially similar totheir counterpalis 65, 67, and 66 in pusher 64. Therefore a detaileddescription of pusher 75 is omitted.

Driving mechanism 71 may comprise a motor 72 and a worm 74 havinghelical threads configured to engage the teeth of rack 76. The worm'srotation axis is identical with the motor axis. The motor axis issubstantially parallel to the needle. Driving mechanism 71 is joinedrigidly to needle 79. Driving mechanism 71 may also comprise one or moreof a controller, a CPU, a computer memory, a man-machine interface, anda power supply (all not shown).

Initially, implant 12 is loaded in its un-deployed shape in the distallumen of needle 79. Push wire 77 of pusher 75 is slidably received inthe proximal end of the lumen of needle 79. The distal end ofstabilizing tube 78 slidably receives the proximal end of needle 79.Rack 76 is configured to engage with worm 73 via interlocking of theteeth of the rack with the threads of the worm. Thus, rotation of theworm causes pusher 75 to move relative to needle 79.

The operation of system 7 is substantially similar to the operation ofsystem 6.

System 7 has the following important advantages: (1) It enablessingle-handed operation by a single operator; (2) In reducesinter-operator variability because of automation, and; (3) the parallelorientation of the motor axis and the needle makes for good ergonomicdesign.

Reference is now made to FIGS. 8A-C, which depict an automatic implantsystem according to some embodiments of the present disclosure.Automatic implant system 8 may comprise a monofilament implant 12, adriving mechanism 80, a push wire 84, and a needle 85.

Implant 12, which may (but does not have to) be a monofilament implant,may be substantially similar to the implant of systems 1 and 3. Needle85 may be substantially similar to needle 11 of system 1. Therefore thedetailed description of implant 1 2 and needle 85 is omitted.

Push wire 84 is substantially similar to push wire 14 of system 1.Therefore a detailed description of push wire 14 is omitted.

Driving mechanism 80 may comprise a motor 81 coupled to a first roller82 and a second roller 83. Motor 81 causes roller 81 to rotate. Pushwire 84 is disposed between the first and the second roller. The forceof friction between the first roller and the push wire causes the pushwire to advance or retract as a result of roller rotation by the motor.

Driving mechanism 80 is joined rigidly to needle 85. Driving mechanism80 may comprise one or more of a controller, a CPU, a computer memory, aman-machine interface, and a power supply (all not shown).

Initially, implant 12 is loaded in its un-deployed shape in the distallumen of needle 85. Push wire 84 is slidably received in the proximalend of the lumen of needle 85. Push wire 84 may initially have asubstantially linear configuration, or it may have a more spatiallycompact form. For example, push wire 84 may initially be rolled on aspool (not shown) in order to save space in system 8.

The operation of system 8 is substantially similar to the operation ofsystem 6.

System 8 has the following advantages: (1) it enables single-handedoperation by a single operator; (2) In reduces inter-operatorvariability because of automation, and; (3) It is conductive towards anergonomic, compact design because the push wire may be initiallydisposed on a spool or in a coil.

Reference is now made to FIGS. 9A-H, which depict a removable implantsystem and method for implant delivery and potential removal accordingto some embodiments of the present disclosure.

System 9 may comprise a pusher 90, a removable implant 91, and a needle92. Pusher 90 may be a hollow tube having a lumen 97 therethrough.Pusher 90 may be made from, for example, a metal such as stainlesssteel, or from plastic.

Removable implant 91 may comprise a monofilament 93, an anchor 94(optional), and a pull-wire 98. Monofilament 93 and pull-wire 98 may beone and the same, or alternatively, monofilament 93 and pull-wire 98 maybe separate components. The proximal end of monofilament 93 may bejoined to the distal end of pull-wire 98 by any suitable method known inthe art, such as welding, brazing, gluing, or by means of a mechanicalconnector. Monofilament 93 and pull-wire 98 may each be joined to anchor94 by, for example, welding, brazing, gluing, or crimping.

Monofilament 93 may be made from a super-elastic alloy, such as nitinol,and may be made from a wire having a circular cross-section, with adiameter between about 0.05 mm and about 1.0 mm (for example).Monofilament 93 may assume an un-deployed, substantially linear state(as in FIG. 9A) or a deployed, functional state (as in FIG. 9E). Themonofilament is constrained to its un-deployed, substantially linearstate by the needle, where the monofilament initially resides in thedistal lumen end thereof. Upon exteriorization from the needle (FIGS. C,D), the monofilament retains its deployed, functional state by virtue ofits super-elasticity.

Implant 91 may have the same uses as implant 12 and may have anyfunctional, deployed shape realizable by twisting monofilament 93.Monofilament 93 may have, but is not limited to have, a functional shapesimilar to that of any of the implants described in the PCT publicationsincorporated by reference herein.

In some embodiments, the functional, deployed state of implant 91 maycomprise a substantially straight stem 95, configured to traverse thewall of a target vessel 16 and secure the implant in place, and afunctional portion 96, configured to perform a beneficial medicalfunction. If, for example, implant 91 is an embolic protection device,then functional portion 96 resembles the shape of a helix. The helix maytrace a shape similar to a shell of a body of revolution, such as, forexample, a sphere, an oval, or an ellipsoid. The helix is implanted withits axis approximately perpendicular to the direction of the vessel(which, in arteries, for example, is the same as the direction of theblood flow). Thus, sufficiently large emboli originating upstream of theimplant may be prevented by the helix coils from flowing past theimplant.

The length of the helix may be greater than the diameter of the vessel,thereby ensuring contact between the distal end of the helix and thevessel wall as the helix is compressed along the direction of its axis.Growth of cells from the vessel wall (neointimal formation) on thedistal end of the helix may further secure implant 91 in place. Thediameter of the helix may be less than the diameter of the vessel,thereby ensuring proper deployment.

Anchor 94 may reside near the proximal end of stem 95. Anchor 94 mayhave, for example, an un-deployed state configured to fit within thelumen of needle 92, and a deployed state configured to adhere tosurrounding tissue. Anchor 94 may be made from nitinol. The anchor maycomprise, for example, one or more barb, one or more protrusion, or oneor more micro-barb.

Pull-wire 98 may have a circular cross section. The diameter ofpull-wire 98 may be between 0.03 mm and 1.0 mm. Pull-wire 98 may bemade, for example, of metal, a super-elastic alloy (nitinol), a polymer,or a biodegradable polymer.

Needle 92 may be made from metal or plastic, with suitable metalsincluding, for example, stainless steel and nitinol. The outer diameterof the needle may range from about 0.2 mm to about 2 mm. The innerdiameter of the needle may range from 0.1 mm to 1.9 mm.

Pull-wire 98 may be configured such that at least a portion of itslidably fits within lumen 97 of pusher 90. Pusher 90 may be configuredto slidably fit within the lumen of needle 92. Pusher 90 may also beconfigured to push either on the proximal end of monofilament 93 or onthe proximal end of anchor 94. Pusher 90 is initially arranged in theproximal end of the lumen of needle 92, proximally to monofilament 93and anchor 94, with at least a portion of pull-wire 98 within pusherlumen 97.

In operation, the operator first assesses the size of target vessel 16.Typically, the assessment is made by, for example, ultrasound,fluoroscopy, CT, or MRI. If, for example, the vessel is an artery or avein, the systolic (minimal) diameter at the implantation site ismeasured and recorded. The operator then chooses an appropriately sizedimplant 91 (preloaded in system 9). If, for example, the functionalportion of monofilament 93 is a helix, then the helix diameter may bechosen undersized between 0.1 mm and 1.0 mm compared to the minimalvessel diameter at the implantation site.

Next, the operator punctures skin 15, advances the tip of needle 92towards the target vessel 16, and punctures vessel 16 using the tip ofneedle 92 (FIG. 9B). All of these steps may be performed under imagingguidance. Possible imaging modalities include ultrasound, highresolution ultrasound, z-ray fluoroscopy, CT, and MRI. The tip is placedin the lumen of the vessel, approximately in the middle of the lumen ofthe vessel. The needle may assume an approximately perpendicularorientation with respect to a plane tangent to the vessel wall at thepuncture site.

Once proper needle position in the vessel lumen has been achieved, theoperator advance pusher 90 towards the distal end of needle 92 whileholding the needle steady (FIG. 9C). This causes implant 91 to beexteriorized from the needle. The exteriorized portion of the implantattempts to resume its functional deployed shape.

The operator continues to push pusher 90 until its proximal end isaligned with the proximal end of the needle. Whenever implant 91comprises a stem 95 and an anchor 94 pusher 90 may be configured suchthat at the position described in FIG. 9D the distance between thedistal end of the pusher and the tip of the needle is approximatelyequal to the length of the stem. In some embodiments, this enablesmonofilament 93 to assume the correct orientation within the vessel.

Next, the operator verifies using a proper imaging modality that themonofilament has correctly assumed its functional shape within thevessel lumen. The operator then withdraws the needle and the pusher. Theanchor slides out of the tip of the needle as the needle is beingpulled, and the pull-wire 98 slides out of pusher lumen 97. Thesituation depicted in FIG. 9E is achieved upon complete withdrawal ofthe needle and the pusher: functional portion 96 of monofilament 93 iswithin the lumen of vessel 16, stem 95 traverses the vessel wall, anchor94 is external to the vessel wall and under skin 15, and pull-wire 98traverses the patient's skin.

Whenever implant 91 is intended for permanent use, the operator inspectsthe implantation site using a suitable imaging modality, such asultrasound, x-ray, fluoroscopy, MRI or CT, anywhere from, for example,minutes to months after the implantation. If the result is satisfactory,the operator clips pull-wire 98 at the level of skin 15 and lifts theskin, thereby placing the entire remainder of the pull-wiresubcutaneously. The situation depicted in FIG. 9F is achieved.

Whenever implant 91 is intended for removal due to the temporary natureof its use, or whenever implant 91 is intended for permanent use but hasto be removed due to safety reasons, the operator pulls the pull wire,thereby causing monofilament 93 to deform as in FIG. 9G and beexteriorized from vessel 16 and from the patient's body (FIG. 9H).Monofilament 93 may exit the vessel wall through the breach in which thestem originally resides.

Note that an automatic system having a hollow pusher may be used todeliver implant 91. Operation is similar to that described above forsystem 9 (except that a motor is used to advance the pusher via a gearand a rack), and therefore detailed description is omitted.

Any and all combinations of the embodiments described herein may bepossible. For example automatic systems in which the implant may beretrieved back into the needle are possible.

Example embodiments have been described herein. As may be notedelsewhere, these embodiments have been described for illustrativepurposes only and are not limiting. Other embodiments are possible andare covered by the disclosure, which will be apparent from the teachingscontained herein. Thus, the breadth and scope of the disclosure shouldnot be limited by any of the above-described embodiments but should bedefined only in accordance with features and claims supported by thepresent disclosure and their equivalents. Moreover, embodiments of thesubject disclosure may include formulations, methods, systems anddevices which may further include any and all elements/features from anyother disclosed formulations, methods, systems, and devices, includingthe manufacture and use thereof. In other words, features from oneand/or another disclosed embodiment may be interchangeable with featuresfrom other disclosed embodiments, which, in turn, correspond to yetother embodiments. One or more features/elements of disclosedembodiments may be removed and still result in patentable subject matter(and thus, resulting in yet more embodiments of the subject disclosure).Furthermore, some embodiments of the present disclosure may bedistinguishable from the prior art by specifically lacking one and/oranother feature, functionality, ingredient or structure which isincluded in the prior art (i.e., claims directed to such embodiments mayinclude “negative limitations”).

Any and all references, articles, publications, patents, patentpublications, and patent applications cited herein are incorporated byreference in their entireties for all purposes. However, mention of anyreference, article, publication, patent, patent publication, and patentapplication cited herein is not, and should not be taken as, anacknowledgment or any form of suggestion that they constitute validprior art or form part of the common general knowledge in any country inthe world.

The invention claimed is:
 1. A removable implant system comprising: apusher, a needle, and a removable implant comprising: a monofilament; apull-wire, and at least one of an anchor and a connector, wherein: thepull wire is affixed to or integral with an end of the monofilament, thepull wire is configured to extend outside the body of a patient apredetermined distance when the implant is implanted to enable theimplant to be pulled out of the vessel, and the implant includes aun-deployed and a deployed state, and wherein the pusher: comprises ahollow tube having a lumen, is configured to push either on a proximalend of the monofilament, a proximal end of the connector, or on aproximal end of the anchor, and is initially arranged in a proximal endof the lumen of the needle, proximally to the monofilament and theanchor or connector, with at least a portion of the pull-wire arrangedwithin the lumen of the pusher.
 2. The system of claim 1, wherein themonofilament and/or pull-wire are affixed to the anchor via at least oneof welding, brazing, gluing, or crimping.
 3. The system of 1, wherein atleast a portion of the monofilament in the deployed state includes asubstantially straight stem configured to traverse a wall of a targetvessel.
 4. The system of 3, wherein the stem is configured to secure theimplant in place.
 5. The system of claim 1, wherein in the deployedstate, the implant further comprising a functional portion configured inthe shape of a helix, wherein the helix traces a shape corresponding toa shell of a body of revolution.
 6. The system of claim 5, wherein thebody of revolution comprises a sphere, an oval, or an ellipsoid.
 7. Thesystem of claim 5, wherein upon implantation, the axis of the helix isconfigured approximately perpendicular to the direction of the vessel.8. The system of claim 5, wherein the length of the helix is configuredto be greater than the diameter of the target vessel.
 9. The system ofclaim 5, wherein the diameter of the helix is less than the diameter ofthe target vessel.
 10. The system of claim 1, wherein the anchor isconfigured to reside near the proximal end of the stem.
 11. The systemof claim 10, wherein the anchor comprises one or more barb, one or moreprotrusion, or one or more micro-barb.
 12. The system of claim 1,wherein the anchor includes an un-deployed state configured to fitwithin the lumen of a delivery needle, and a deployed state configuredto adhere to surrounding tissue.
 13. The system of claim 1, wherein thepull-wire includes a circular cross section with a diameter of betweenabout 0.03 mm and 1.0 mm.
 14. The system of claim 1, wherein the needlecomprises metal or plastic, and wherein an outer diameter of the needleranges between about 0.2 mm to about 2 mm, and/or an inner diameter ofthe needle ranges between 0.1 mm to 1.9 mm.
 15. The system of claim 1,wherein the pull-wire is configured such that at least a portion thereofis slidably fits within lumen of the pusher.
 16. The system of claim 1,wherein the pusher is configured to slidably fit within the lumen of theneedle.